Irhythm Technologies Inc Orange County

FDA Filings

This page includes the latest FDA filings for Irhythm Technologies Inc Orange County. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3008363157
• FEI Number: 3008363157
• Name: iRhythm Technologies, Inc. Orange County
• Owner & Operator: iRhythm Technologies, Inc.
• Contact Address: 699 8th St Suite 600; San Francisco CA 94103 US
• Official Correspondent:
  • Rich Laguna
  • x-415-6325700-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 11085 Knott Ave Ste B ; Cypress, CA 90630 US
• Establishment Type:
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Repack or Relabel Medical Device

FDA Filings

Device Company	Device	Date
PMN K163512 | DXH iRhythm Technologies, Inc. Orange County [iRhythm Technologies, Inc.]	Zio? AT Patch	2017-09-01
PMN K163512 | DXH iRhythm Technologies, Inc. Orange County [iRhythm Technologies, Inc.]	Zio? AT Gateway	2017-09-01
PMN K163512 | DXH iRhythm Technologies, Inc. Orange County [iRhythm Technologies, Inc.]	ZEUS System	2017-09-01
PMN K163512 | DSI iRhythm Technologies, Inc. Orange County [iRhythm Technologies, Inc.]	Zio? AT Patch	2017-09-01
PMN K163512 | DSI iRhythm Technologies, Inc. Orange County [iRhythm Technologies, Inc.]	Zio? AT Gateway	2017-09-01
PMN K163512 | DSI iRhythm Technologies, Inc. Orange County [iRhythm Technologies, Inc.]	ZEUS System	2017-09-01
PMN K163512 | DSH iRhythm Technologies, Inc. Orange County [iRhythm Technologies, Inc.]	Zio? AT Patch	2017-09-01
PMN K163512 | DSH iRhythm Technologies, Inc. Orange County [iRhythm Technologies, Inc.]	Zio? AT Gateway	2017-09-01
PMN K163512 | DSH iRhythm Technologies, Inc. Orange County [iRhythm Technologies, Inc.]	ZEUS System	2017-09-01
PMN K163512 | DQK iRhythm Technologies, Inc. Orange County [iRhythm Technologies, Inc.]	Zio? AT Patch	2017-09-01
PMN K163512 | DQK iRhythm Technologies, Inc. Orange County [iRhythm Technologies, Inc.]	Zio? AT Gateway	2017-09-01
PMN K163512 | DQK iRhythm Technologies, Inc. Orange County [iRhythm Technologies, Inc.]	ZEUS System	2017-09-01
LWK iRhythm Technologies, Inc. Orange County [iRhythm Technologies, Inc.]	Razor	2017-09-01
KOY iRhythm Technologies, Inc. Orange County [iRhythm Technologies, Inc.]	Tape Remover Pad	2017-09-01
PMN K121319 | DSH iRhythm Technologies, Inc. Orange County [iRhythm Technologies, Inc.]	Zio? XT Patch	2012-12-26
PMN K121319 | DSH iRhythm Technologies, Inc. Orange County [iRhythm Technologies, Inc.]	Zio? XT Patch CE	2012-12-26